What Next for Arachnoiditis Patients?

By Pat Anson, Editor

A pioneering two-day conference on arachnoiditis has ended in Helena, Montana with dozens of  patients armed with new information about the chronic and disabling spinal disease.

Many are also left wondering who will treat them and how to pay for it.

"We practitioners need your help and you need our help," says Forest Tennant, MD, who is the world's foremost authority on arachnoiditis, a progressive and incurable inflammation of the spinal cord that leaves most people who have it with severe chronic pain.

Tennant, who treats about 60 arachnoiditis patients from around the country at his pain clinic in West Covina, California, has developed a complex and unique therapy for arachnoiditis that combines pain medication, anti-inflammatory drugs, vitamins and hormones. Once bedridden or using walkers, several of his patients were healthy enough to make the long trip to Montana to hear him speak.

"I would not dare prescribe these drugs if I didn't have control of the opioids and everything else you're doing. These things are hazardous in the hands of the inexperienced," he warned.

At age 75, Tennant knows it is time for other doctors to learn and start practicing his treatment methods.  But he and his patients face a dilemma. Most pain management doctors and specialists already have a full patient load and Tennant himself is not taking new patients.

"Every good specialist in this country is booked. They're not available and they don't know anything about this anyway," says Tennant.

"Pain management really is its own specialty now and if they're not in that field, they're not going to help you do this. These hormones are going to have to be done by the same doctor that manages your pain and manages your inflammation. It's going to have to be done by the same practitioner."   

If attendance at the conference is any indication, finding doctors willing to learn and practice Tennant's treatment protocol will be difficult. Invitations went out to over two thousand practitioners in Montana, but only a handful showed up.  No one from the Montana Medical Association or the Montana Board of Medical Examiners attended.

"The problem with this protocol in the conventional medical world is that this crosses disciplines. We're talking rheumatologists, we're talking endocrinologists, and that's where conventional medicine gets stuck," says Christine White, ND, a naturopathic physician from Missoula who attended the conference. "Conventional medicine has evolved into this realm where the general practitioner doesn't do a lot. They refer out (to specialists) and what we need to do as physicians is get general practitioners willing to take on more rings of this problem."

The problem may be a bigger one that anyone imagines. Tennant estimates as many as one million Americans may suffer from arachnoiditis, many of them misdiagnosed with “failed back syndrome” or other spinal problems.

Most people get the disease when the arachnoid membrane that surrounds their spinal cord is damaged during surgery or punctured by a needle during an epidural steroid injection. Inflammation sets in and can spiral out of control, forming scar tissue that cause spinal nerves to stick together. That leads to adhesive arachnoiditis and neurological problems, which can cause burning or stinging pain that can be felt from head to toe.

Insurance Won't Pay the Bills

Besides getting treatment, another common problem faced by arachnoiditis sufferers is their insurance coverage.

"The reimbursement structure is part of the problem and the reason why I ended up with adhesive arachnoiditis," says Terri Anderson, who as a federal employee was covered by Blue Cross Blue Shield when she went to get treatment for back pain.

"I think the doctors and surgeons looked at my Blue Cross Blue Shield and they wanted to do epidural steroid injections and spinal surgery. Blue Cross had good coverage for all these invasive procedures, so I think they have some culpability," she said

Like many arachnoiditis patients, Anderson is not reimbursed for the unusual drugs and hormone therapy that she gets "off label" from Dr. Tennant or for the cost of traveling to see him in California. Her out of pocket expenses add up to about $200 a month.

"My co-pays for my medications are about $500 a month," says Nancy Marr of Los Angeles, who is insured through Medicare and a supplemental policy with AARP. Marr doesn't have to travel far to see Tennant, but she does have to pay out-of-pocket for his services.

"To participate in this kind of a program at this point in time would end up costing people a tremendous amount of out-of-pocket costs," she says.

While all of this is discouraging, the mood was anything but gloomy at the conference. For many, including this reporter, it was their first chance to meet and interact with people they've been communicating with online for years. That sense of community and a common goal stirs optimism. And so does the knowledge that the conference may have laid the groundwork for a treatment that could ultimately benefit thousands of people who are suffering.

New Treatment Gives Hope to Arachnoiditis Patients

By Pat Anson, Editor

Dozens of pain patients and physicians are meeting in Helena, Montana this weekend at a pioneering medical conference focused on arachnoiditis -- a progressive spinal disease long thought to be incurable that leaves many patients disabled with chronic back pain.

The conference is being led by Dr. Forest Tennant, a pain management physician from southern California, who has developed a unique protocol to treat arachnoiditis with a combination of pain medication, hormones and anti-inflammatory drugs. Unable to get the same type of therapy where they live, desperate patients from as far away as Maine, Alaska and Florida have been traveling to see Tennant for treatment at his pain clinic in West Covina, a Los Angeles suburb.

“We’re making history today. In all my wildest dreams I never thought we’d be having an arachnoiditis seminar in my home state,” said Gary Snook, a Montana native and a patient of Tennant for over a decade. “If there is one thing that we can learn today, it's that this hopelessly incurable disease that we suffer from is not as hopeless as we once thought.”

It was Kate Lamport’s idea to have Tennant give a seminar on arachnoiditis in her hometown of Helena. The 33-year old mother of four developed spinal pain after a series of epidurals for child birth and bulging discs in her back. She was diagnosed with arachnoiditis last year and went to see Dr. Tennant in California.

“As I learned more about arachnoiditis, I realized how many people were struggling just getting a diagnosis and treatment,” Lamport says. “There are so many people who want to go see Dr. Tennant, but they can’t. He’s booked and they can’t afford to travel, so I wanted to put something together to give people an opportunity to come see him and learn from him.”

The arachnoitditis conference is not just for patients. Several physicians and practitioners are also attending, hoping to learn some of the therapies Tennant has developed over the past decade.  

FOREST TENNANT, MD

“Physicians are simply not getting the education and training they need,” says Tennant. “I am just so frustrated by all of the patients who are calling and all of the physicians that are calling, the demand for knowledge. And so we need a new way of doing some training and some education. And this is my first attempt to step outside of the educational box, if you will, and see if this is a mechanism that will successful.”

Tennant has conducted extensive research on the disease and has launched an Arachnoiditis Education Project for physicians. He says patients respond much better to treatment when arachnoiditis is in its early stages, when the inflammation is limited to the arachnoid membrane that surrounds the spinal cord.

As the disease progresses, the inflammation causes scar tissue to build around spinal nerves, which begin to adhere or stick together, leading to adhesive arachnoiditis -- which causes severe pain and other neurological problems, such as burning and stinging sensations that can radiate from the back down to the feet. More advanced stages of arachnoiditis can lead to paralysis.

Growing Number of Cases

Once considered rare, arachnoiditis is appearing more frequently as interventional pain physicians perform more surgeries and epidural steroid injections as alternatives to opioids for back pain. Tennant estimates as many as one million Americans may suffer from arachnoiditis, many of them misdiagnosed with “failed back syndrome” or other spinal conditions. He says every pain practice in the country needs to familiarize itself with arachnoiditis.

“We’ve had a decade of some marvelous science that no one talks about. We talk about opioids, epidurals and all the problems, but we don’t talk about the good things that have happened scientifically that have helped us develop a protocol to treat spinal cord inflammation,” Tennant told Pain News Network.

One discovery is the role that specialized cells in the brain and spinal cord – called microglial cells -- have in protecting and nourishing nerve cells. When glial cells become hyperactive in response to an injury, they trigger an inflammatory response that causes chronic pain.  That inflammation needs to be addressed with corticosteroids, says Tennant, or pain medications will never be effective.

The second discovery is that the central nervous system uses oxytocin, progesterone, pregnenolone and other hormones to regulate microglial cells. Hormone supplements and injections can be used to boost hormone levels and keep microglial cells at healthy levels.

“These two discoveries are profound. If it had not been for these two things, we would not be doing this seminar. The protocol that I’ve developed is because of these discoveries,” says Tennant.

Treatment Lowers Use of Opioids

Tennant’s treatment protocol is complex and requires the “off-label” use of several different medications. But many of his patients report they’ve been able to lead more productive and active lives, while reducing their use of opioid pain medication.

“It’s allowed me to be more active. I’m less exhausted, I get around better. I don’t have to use a walker as much,” says Rhonda Posey of Texas, who started seeing Tennant in April. “I’m smiling more. I’ve got better spirit and I have hope.”

“I actually believe that I was close to dying last year,” says Nancy Marr of Los Angeles, who suffered from arachnoiditis for a decade before she started seeing Tennant last year. “I went to see Dr. Tennant because my pain physician all of a sudden was threatening to withdraw all of my opioid medication.”

Blood tests revealed that Marr had low hormone levels and her inflammatory markers were “off the charts.” After treatment by Tennant, she’s only taking half the oxycodone she used to need for breakthrough pain.   

“My inflammatory markers are within normal range and my hormone levels are up. I’m feeling much better. I do have flares, but I can do a lot more,” she says.

“I’m on less pain medication now than I’ve been on for years,” said Jerry Davis of Arizona, who believes his back problems stem from a case of meningitis. “I got off the fentanyl. I got off all the other stuff."

Davis said he can usually sleep through the night, no longer has to spend some days in bed, and can lead a fairly normal life.

"I wasn’t in a wheelchair, but I probably would be by now if I hadn’t found him,” he says.

At age 75, Tennant isn’t sure how much longer he’ll be practicing. But he’s determined to share what he’s learned with other doctors, so they can provide the same treatment and hope he's given to arachnoiditis patients. Tennant is planning to host another arachnoiditis seminar in Hattiesburg, Mississippi this October.

Medicare Drops Pain Questions in Patient Survey

By Pat Anson, Editor

The Centers for Medicare and Medicaid Services (CMS) has caved into political pressure from Congress and healthcare lobbying organizations by proposing to drop all questions related to pain in patient satisfaction surveys.

The proposed rule change is the latest in a series of steps by the federal government aimed at fighting the so-called opioid epidemic by reducing the prescribing of narcotic pain medication. The policies are meant to prevent addiction and abuse, but have left many pain patients without access to opioids, and feeling marginalized and abandoned by the healthcare system.

At issue in the Medicare rule change is a funding formula that requires hospitals to prove they provide quality care through patient satisfaction surveys. The formula rewards hospitals that provide good care and are rated highly by patients, while penalizing those who do not. 

Critics claim that three pain care questions in the survey -- known as the Hospital Consumer Assessment of Healthcare Providers and Systems survey (HCAHPS) -- encourage doctors to overprescribe opioid pain medication to boost their hospital's scores.

"While there is no empirical evidence of this effect, we propose to remove the pain management dimension from the Hospital Value-Based Purchasing program to eliminate any potential financial pressure clinicians may feel to overprescribe pain medications," CMS said in a statement.

"CMS continues to believe that pain control is an appropriate part of routine patient care that hospitals should manage and is an important concern for patients, their families, and their caregivers."

CMS has been under intense political pressure over the last few months to drop the pain questions. In March, 26 U.S. senators sent a letter to Health and Human Services Secretary Sylvia Mathews Burwell claiming "the evidence suggests that physicians may feel compelled to prescribe opioid pain relievers in order to improve hospital performance on quality measures."

Several physician groups have also made the same claim, without offering anything more than anecdotal evidence. Physicians for Responsible Opioid Prescribing (PROP)  said the survey "fosters dangerous pain control practices" and even the American Medical Association recently said the surveys "are clearly motivating forces for opioid prescribing."

A top Medicare official disputed those claims in an article published in JAMA. 

"It has been alleged that, in pursuit of better patient responses and higher reimbursement, HCAHPS compels clinicians to prescribe prescription opioids. However, there is no empirical evidence that failing to prescribe opioids lowers a hospital’s HCAHPS scores," wrote Lemeneh Tefera, MD. “Nothing in the survey suggests that opioids are a preferred way to control pain.”

These are the three pain questions in the CMS patient survey::

During this hospital stay, did you need medicine for pain?

During this hospital stay, how often was your pain well controlled?

During this hospital stay, how often did the hospital staff do everything they could to help you with your pain?

The agency said it would develop and "field test" alternative questions related to pain and include them in the survey. Public comments on the proposed rule change will be accepted until September 6, 2016.

CMS said the rule changes "are based on feedback from stakeholders, including beneficiary and patient advocates, as well as health care providers, including hospitals, ambulatory surgical centers and the physician community."

While some politicians and lobbyists may support the CMS decision, pain patients clearly do not. 

Pain News Network and the International Pain Foundation recently conducted a survey of over 1,250 pain patients. Nine out of ten said patients should be asked about their pain care in hospital satisfaction surveys. Over half rated the quality of their pain treatment in hospitals as poor or very poor, and over 80 percent said hospital staffs are not adequately trained in pain management. 

The Centers for Disease Control and Prevention has adopted guidelines that discourage primary care physicians from prescribing opioids or chronic pain. The Obama administration has also proposed spending over a billion dollars on opioid addiction treatment. Not one cent is proposed for pain research or for funding alternative treatments for pain.  

Post-Operative Chronic Pain Costly for Hospitals

By Pat Anson, Editor

A new study by Canadian researchers has documented the long-term cost that chronic pain can have when patients are sent home from a hospital with post-surgical pain that doesn't go away.

Researchers at Toronto General Hospital (TGH) and University Health Network (UHN) estimate that about 15 percent of complex post-operative patients develop moderate to severe chronic pain, and have significant disability that requires the use of opioids for long-term pain relief.

The estimated additional cost of treating those patients at TGF ranges from $2.5 million to $4.1 million year, due to repeat doctor visits, extended hospital stays, and re-admissions.

On average, chronic pain patients stay five to seven days longer in the hospital for the same condition as patients who do not have chronic pain.

"We need to break the cycle of pain before it becomes chronic. It is much harder to treat someone when the pain is entrenched, and the window of opportunity is lost," says senior author Hance Clarke, MD, who is Director of the Transitional Pain Service in the Anesthesia Department and Pain Management at TGH and a clinical researcher at the Toronto General Research Institute.

Clarke says it takes about six months for post-surgical pain to develop into chronic pain, and it’s important to intervene before that happens. About 13 percent of TGH surgical patients already have chronic pain when the enter the hospital, which can worsen after surgery.

The cost of treating chronic pain in Canada is estimated at between $47 billion and $60 billion a year -- more than HIV, cancer and heart disease combined. It costs about $5,000 a year to care for a chronic pain patient in Ontario.

"Pain is an epidemic, and the costs to the healthcare system, as well as to patients, are staggering," said Clarke.

Up to 70 percent of patients after major surgery are discharged from the hospital with a prescription for opioids. Three months later, over one in four (27%) are still using them.

"Identifying at-risk patients, typically those who have pre-existing pain, mental health issues, chronic use of opioids before surgery, is critical, so that we can develop follow-up plans, and educate patients and other healthcare providers,'' saysClarke. "We need to give patients the tools to manage their pain, should it become problematic."

The study findings are published in the journal Pain Management.

Ironically, the Canadian study highlighting the need for early pain intervention in hospitals comes at a time when politicians and some leading health officials in the U.S. are calling for an end to hospital surveys that ask patients about the quality of their pain care.

The American Medical Association recently said the patient surveys, which are required by Medicare, “are clearly motivating forces for opioid prescribing.”

Medicare says there is no evidence to support that claim, but has proposed dropping all pain questions from the survey.

Medical Marijuana Lowers Prescription Drug Costs

By Pat Anson, Editor

Prescriptions for pain relievers and other medications have fallen significantly in states where medical marijuana is legal, according to a new study published in the journal Health Affairs.

Researchers at the University of Georgia analyzed data from Medicare’s Part D prescription drug program in 2013 – a year when 17 states and the District of Columbia had legalized medical marijuana -- and estimated there was a cost savings of $165 million in prescription drug claims.

The results suggest that if all 50 states had medical marijuana laws that year, the overall savings to Medicare would have been around $468 million.

“Generally, we found that when a medical marijuana law went into effect, prescribing for FDA approved prescription drugs under Medicare Part D fell substantially,” said lead author Ashley Bradford, a recent graduate from the University of Georgia who will pursue her master's degree in public administration this fall.

"The results suggest people are really using marijuana as medicine and not just using it for recreational purposes.”

Compared to Medicare Part D's 2013 total budget of $103 billion, the $165 million in estimated savings only amounts to half of one percent. But it shows the potential for medical marijuana as an alternative to prescription drugs for a wide range of ailments, including pain. Until now, little was known about the impact medical marijuana was having on healthcare spending.

"We realized this question was an important one that nobody had yet attacked," said co-author W. David Bradford, who is the Busbee Chair in Public Policy in the UGA School of Public and International Affairs.

Researchers studied data on all prescriptions filled by Medicare Part D patients from 2010 to 2013, and then narrowed down the results to focus only on nine conditions for which marijuana might serve as an alternative treatment:  anxiety, depression, glaucoma, nausea, pain, psychosis, seizures, sleep disorders and muscle spasticity (stiffness).

The biggest reduction in prescriptions was for analgesics used to treat pain. Doctors in states where medical marijuana was legal wrote an average of 1,826 fewer daily doses for analgesics in 2013.

Currently 24 states and the District of Columbia have laws allowing for medical marijuana. The federal government still considers marijuana illegal, however the Drug Enforcement Administration is reviewing marijuana’s status as Schedule I controlled substance. Reclassifying marijuana could make it legal for medical use in all 50 states.

“Our findings and existing clinical literature imply that patients respond to medical marijuana legislation as if there are clinical benefits to the drug, which adds to the growing body of evidence suggesting that the Schedule I status is outdated,” said Bradford. “Lowering the costs of Medicare and other programs is not a sufficient justification for approving marijuana for medical use, a decision that is complex and multidimensional. Nonetheless, these savings should be considered when changes in marijuana policy are discussed.”

Previous studies have found a significant decline in use of opioid pain medication in patients who use marijuana and that marijuana users are not at greater risk of alcohol and drug abuse.        

Acetaminophen Linked to Autism and ADHD

By Pat Anson, Editor

An over-the-counter pain reliever widely used by pregnant women has been linked to autism and attention deficit problems in their children, according to researchers.

In a new study involving over 2,600 Spanish women and their children, published online in the International Journal of Epidemiology, researchers said maternal use of acetaminophen – also known as paracetamol -- appears to increase the risk of autism spectrum disorder (ASD) in boys. There was also a “weak” association between acetaminophen and attention deficit disorder (ADHD) in both male and female children.

“To our knowledge, this is the first prospective study to report an independent association between the use of acetaminophen during pregnancy and autism spectrum symptomatology in exposed children. It is also the first paper to report differential gender effects of prenatal acetaminophen exposure on neurodevelopment,” the researchers said.

About 40 percent of the women in the study used acetaminophen while pregnant. Their children were evaluated at 1 and 5 years of age.

The researchers speculated that boys may metabolize acetaminophen differently than girls, accounting for the greater risk of autism.

“Animal studies have suggested that male mice undergo greater toxicity than female mice after being administered a similar dose of acetaminophen. Furthermore, the male brain may be more vulnerable to early life stressors  and this could explain why neuropsychiatric disorders of childhood, such as ASC and ADHD, are more prevalent in male children,” they said.

Acetaminophen (paracetamol) is the world’s most widely used over-the-counter pain reliever. It is the active ingredient in Tylenol, Excedrin, and hundreds of other pain medications.

In a review of the study, the UK’s National Health Service (NHS) said researchers failed to prove a clear link between maternal use of acetaminophen and autism or ADHD.

“This research cannot prove paracetamol use is directly responsible for these findings. Not all links were statistically significant – for example, paracetamol was not linked with ADHD when looking at full diagnostic criteria, or with ASD when looking at the full sample of children,” the NHS said. “Importantly, no link was found with developmental or intellectual outcomes in the child.

“The current viewpoint is that occasionally using paracetamol as needed, and at recommended doses, is safe during pregnancy. This study has not provided sufficient evidence to the contrary to change this advice.”

Over 50 million people in the U.S. use acetaminophen each week to treat pain and fever. The pain reliever has long been associated with liver injury and allergic reactions such as skin rash.

Another recent study of pregnant women found that Lyrica (pregabalin) – a medication also prescribed for pain – appears to  increase the risk of major births defects, including heart defects and structural problems with the central nervous system.

Doctor: Pain Has Never Killed Anyone

By John Hsu, MD, Guest Columnist

The opioid problem with medicine began when The Joint Commission promoted the concept that pain is the fifth vital sign, and that patients should be asked about their pain and the quality of their treatment.

Ten years ago, when my hospital was undergoing an inspection, I clearly remember the examiner chastising me about my multimodal pain therapy and her concern that it would leave patients in pain. Clearly, doctors were put on alert that they could be sued for leaving a patient in pain.

Pain as a fifth vital sign is really contraindicated. Pain has never killed anyone, but opioids killed over 29,000 Americans last year. They don’t have any vital signs.

Doctors are now at a crossroads. The Centers for Medicare and Medicaid (CMS) has attached patient satisfaction scores to reimbursement. A patient comes to the office and demands pain meds. If the doctor prescribes pain meds, the doctor can not only lose their license, but go to jail for murder, as Dr. Lisa Tseng from Rowland Heights, CA has. Or they can risk poor patient satisfaction scores and, if they are a part of an accountable care organization (ACO), risk losing their employment.

Why are doctors burned out? Because other people have come between the doctor-patient relationship. I had a nurse tell me that she would put her 21 years in ICU up to my skills as a physician, to which I retorted that she still had to take orders from me.

This loss of respect amid the loss of autonomy is frightening.  It is one of the major complaints doctors describe when they are asked about burnout and why they are leaving medicine. The healthcare team is no longer run by the doctor. It is run by nurses from the quality review department, enforcing best practices on physicians so protocols and guidelines set up by the government are followed.

I call that evidence-less based medicine. Guidelines have destroyed the doctor-patient relationship. Does the government really have patient interests at heart or is the government really just a big micromanager? 

Perhaps the answer to the opioid problem lies with outside-the-box thinking. What if we correctly promote that pain must be present for us to live and that some pain is good?  Unlike Patrick Henry, who said “Give me liberty or give me death,” I personally would prefer to say, "Give me pain and give me liberty, but don't give me death."

Patients have a responsibility to take care of their own health. All prescriptions written by doctors and filled by pharmacists were written correctly. Yet some patients are not compliant and take too many pills. We all know we should not overeat, but 70% of the American public is obese. Humans are their own worst enemies.  Unpopular as this stance may seem, it must be mentioned that while the population of the U.S. is 324 million, 259 million opioid prescription were written in in 2012. 

The Joint Commission's edict that no patient should be in pain changed patients' expectations. Everyone expected and demanded to be pain free. But focusing on the short term discomfort experienced by those in pain ignores the long term goal of improving a patient's health.

The government (FDA, DEA, CDC and policymakers) has decided to restrict opioid prescriptions. This is logical, but does not address human nature. The end result has been that addicts and patients who cannot get prescription opioids have turned to cheaper and easily attainable $5 bags of heroin. Heroin deaths have quadrupled in the last decade. In 2015, over 10,000 people died from heroin overdoses. The situation is rapidly worsening, as illicit drug makers are mixing heroin with fentanyl, which is 70 times stronger than morphine. 

The opioid conundrum has become readily apparent. Opioids may be the best treatment for pain, but they raise the risk of addiction, respiratory suppression, and death.

Cultural Shift Needed in Patient Education

The solutions needed for this dilemma include a cultural shift in the education physicians and nurses give to patients and the perception that pain is bad. We have to forsake the short term treatment of pain with opioids and look to the long term goal of preserving human life.

Let’s look at patient satisfaction scores and medical education. Studies show that when patient satisfaction scores are considered in prescribing care to patients, their care is not only more expensive, but often worse -- resulting in higher morbidity and mortality. Despite this evidence, CMS has connected patient satisfaction scores to hospital reimbursement. 

The Joint Commission has promoted an atmosphere where patients believe that they should never have to suffer pain and have the right to be “pain free.” More opioids were prescribed, but often patients demanded and even threatened doctors if they did obtain pain relief.  Doctors were accused of elder abuse and medical negligence if they did not prescribe pain medication, despite the lack of medical indications or consideration of narcotic alternatives. 

Fast forward a decade and suddenly the government realized that more addicts existed and more people were overdosing. Nearly 19,000 people died in 2014 from opioid prescription overdoses legally obtained from physicians and correctly filled by pharmacists.  The government ironically declared that doctors were to blame. 

The government could not blame patients for the problem, even though the general consensus is that patients were non-compliant with their prescribed opioid doses and shared their narcotics with family and friends.  Patients were not blamed for their actions because they vote and they reelect government officials. 

The government’s solution to the current opioid overdose epidemic was a policy change.  The FDA and CDC forced physicians to limit opioid prescriptions, and increased the difficulty of prescribing opioids by changing the scheduling of hydrocodone from Schedule III to Schedule II.  The government also began criminally prosecuting physicians for murder, even though the patient was noncompliant and overdosed on opioids. 

Why did the The Joint Commission, representing the federal government, have to get involved in medicine?  Why should a federal entity interfere with the doctor-patient relationship? It is not our fault that policies make us do certain things we believe are not in the best interest of the patient.

The Hippocratic Oath directs physicians to not allow outside influences effect their patient care decisions. I would like to see medicine practiced so that the government can no longer come between patients and their doctors. Let us amend the constitution so that there is a separation of medicine and state, just like the separation of church and state.  

JOHN HSU, MD

John Hsu, MD, has been practicing anesthesia at 600-bed hospital inCalifornia for the past 23 years.

Dr. Hsu recently founded MedRev Pharma, a pharmaceutical development company which is developing a safer opioid that minimizes the risk of abuse, addiction and respiratory depression.  Dr. Hsu is also the Director of SBS Medical Management, a consultation service that addresses issues relating to healthcare reform policies, physician practice management, and medical devices.

Pain News Network invites other readers to share their stories with us.  Send them to:  editor@PainNewsNetwork.org. 

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

DEA: ‘Hundreds of Thousands’ of Fake Pills in U.S.

By Pat Anson, Editor

A new report from the U.S. Drug Enforcement Association about the national threat posed by heroin may tell us more about another illegal opioid – fentanyl -- than it does about heroin.

The recently unclassified report, which you can read by clicking here, documents a stunning 248% increase in overdose deaths involving heroin from 2010 to 2014. Over 10,500 Americans died from heroin overdoses in 2014 alone.

But it turns out many of those deaths may have actually been caused by fentanyl, a synthetic opioid 50 to 100 times more potent than morphine. We’re not talking about pharmaceutical grade fentanyl legally prescribed in transdermal patches or lozenges to treat chronic pain, but bootleg white powder fentanyl manufactured in China and smuggled into the U.S.

The DEA says there were 5,544 deaths caused by fentanyl and other synthetic opioids in 2014, but admits “the true number is most likely higher.” The actual number is not known because many coroners and state crime laboratories do not test for fentanyl.

What medical examiners do often test for in suspected drug overdoses is heroin – and that is why the statistics on heroin should be taken with a grain of salt. Because the real culprit is often fentanyl.

“Most of the areas affected by the fentanyl overdoses are in the eastern United States, where white powder heroin is used,” the DEA report states. “Fentanyl is most commonly mixed with white powder heroin or is sold disguised as white powder heroin.”

Massachusetts and Rhode Island – two eastern states with big heroin problems – recently came out with reports showing that fentanyl, not heroin, was to blame for nearly 60 percent of their opioid overdose deaths. The states used toxicology tests that are far more accurate than the death certificate codes used by the DEA and the Centers for Disease Control and Prevention.  

The DEA and CDC overdose statistics are muddied even further by the fact that heroin deaths are “often undercounted” and blamed on morphine, a prescription painkiller.

“Many medical examiners are reluctant to characterize a death as heroin related,” the DEA admits. “Thus many heroin deaths are reported as morphine-related deaths. Further, there is no standardized system for reporting drug related deaths in the United States. The manner of collecting and reporting death data varies with each medical examiner and coroner.”

Why does any of this matter to chronic pain patients? Because deaths caused by fentanyl and heroin are being lumped together with overdoses caused by prescription painkillers. The CDC has been doing it for years to build a case against opioid pain medication and to justify its release of guidelines that discourage doctors from prescribing opioids for chronic pain.

Prescribing of opioid pain medication has been in decline for several years and hydrocodone prescriptions have fallen by 30 percent since 2011. Yet the CDC claims there was a sudden spike in opioid analgesic deaths in 2014 and that nearly 19,000 Americans died.

Some pain patients – no longer able to get opioids legally – are turning to the streets for pain relief. And the DEA report acknowledges that patients are now being targeted by drug dealers selling counterfeit medication.

“Hundreds of thousands of counterfeit prescriptions pills, some containing deadly amounts of fentanyl, have been introduced into U.S. drug markets, exacerbating the fentanyl and opioid crisis,” the DEA report says. “Motivated by enormous profit potential, traffickers are exploiting high consumer demand for prescription medications by producing inexpensive, fraudulent prescription pills containing fentanyl.

“The equipment and materials necessary to produce these counterfeit drugs are widely available online for a small initial investment, greatly reducing the barrier of entry into production for small-scale drug trafficking groups and individuals. In addition, fentanyl pill press operations have been identified in the United States, Canada, and Mexico, indicating a vast expansion of the traditional illicit fentanyl market.”  

The DEA says counterfeit medication caused at least 19 deaths this year in California and Florida. But, like the statistics for fentanyl and heroin, the actual number may never be known.   

When asked to comment on the DEA report, a spokesperson for the CDC told us that "the large distribution of pills seems to be a new threat that we are still assessing."

Should Pain Patients Be Prescribed Naloxone?

By Pat Anson, Editor

A medication that rapidly reverses the effects of an opioid overdose should be prescribed to patients taking opioid analgesics for chronic pain, according to a study published in the Annals of Internal Medicine.

But the study fails to address the soaring cost of naloxone and whether pain patients can afford it.

In a pilot program at primary care clinics in San Francisco, doctors gave naloxone “rescue kits” to nearly 2,000 pain patients on long-term opioid therapy, and found that they had 63 percent fewer opioid-related emergency rooms visits in one year than patients not prescribed naloxone. Naloxone is usually administered by injection to reverse the effects of an overdose and has been credited with saving thousands of lives.

Naloxone has rapidly gone mainstream in recent years as public health officials have reacted to the so-called opioid epidemic. The rescue kits are increasingly being carried by police and paramedics, and given to heroin and opioid addicts to keep at home. But they are not usually prescribed to people taking opioids for pain relief.

Researchers say being given a rescue kit and being trained how to use one may have made pain patients in the study more careful with their opioids, without the kits ever actually being used.

“The educational component of the intervention may have reduced ED (emergency department) visits by altering risky behaviors, thus preventing overdoses in the first place,” said lead author Alexander Walley, MD, in an editorial also published in the Annals of Internal Medicine. "Receiving a naloxone rescue kit may have served as tangible reinforcement of overdose prevention messages, though this warrants further study.”

university of washington

The Centers for Disease Control and Prevention recently released opioid prescribing guidelines that encourage physicians to prescribe naloxone to high-risk patients.

“Providers should incorporate into the management plan strategies to mitigate risk, including considering offering naloxone when factors that increase risk for opioid overdose, such as history of overdose, history of substance use disorder, or higher opioid dosages (≥50 MME), are present,” the guidelines state.

The Food and Drug Administration is also encouraging the widespread distribution of naloxone. Last November, the agency approved Narcan -- a naloxone nasal spray – as an emergency life-saving medication. The approval came less than four months after the FDA received a new drug application from Adept Pharma. The process usually take the agency years to complete. 

“Anyone who uses prescription opioids for the long term management of chronic pain, or those who take heroin, are potentially at risk of experiencing a life-threatening or fatal opioid overdose where breathing and heart beat slow or stop,” Adept Pharma said in a statement.

The company said Narcan would be available at a “public interest price” of $75 for a package of two nasal sprays when ordered by public health  organizations.  For consumers, however, Narcan costs nearly twice as much. Healthcare Bluebook lists the retail “fair price” of Narcan at $134.

Prices for naloxone have soared in recent years as demand for the medication has increased. Some hospital emergency departments have run out of naloxone, according to Politico, and some drug makers are being accused of price gouging.

"You have increased demand and a few people who control the pricing, so they can charge whatever they want," said Eliza Wheeler, who runs an overdose prevention project in Northern California, in Politico.

Generic versions of naloxone cost only pennies in other countries, but in the U.S. an auto inject version sold by Kaleo Pharma soared from $575 for a two-dose package to $3,750, according to Truven Health Analytics.

“Opioid abuse is an epidemic across our country, yet drug companies continue to rip off the American people by charging the highest prices in the world because they have no shame,” Democratic presidential candidate Sen. Bernie Sanders said in a statement. “The greed of the pharmaceutical industry is killing Americans.” 

Many drug makers offer discounts on naloxone rescue kits to hospitals, schools, non-profits and public agencies, but patients often wind up paying full price.

Wearable Devices Could Monitor Opioid Use

By Pat Anson, Editor

We’ve written before about wearable medical devices, a fast growing $2.8 billion industry aimed at helping us lead healthier lives. Some devices relieve pain, while others monitor your blood pressure, pulse, body temperature, sleep, or even the number of calories you’re burning.

One device can even be used as a sort of “Big Brother” to monitor your use of opioid pain medication.

A small study published in the Journal of Medical Toxicology followed 30 emergency room patients who were given opioids for severe acute pain. For four months the patients wore a Q sensor, a wristband device made by Affectiva,  a Massachusetts company that specializes in technology that tracks and measures human emotions.

The wristband only monitors skin temperature and locomotion (movement) of the user, but researchers found the data can be used to track and predict opioid use with a fair degree of accuracy.

Researchers say people who take opioids daily for pain or addiction treatment (methadone and buprenorphine) are more likely to fidget or show restless activity when they feel cravings for medication. A sudden decrease in movement and an increase in skin temperature can be signs that they had taken a dose of medication.   

affectiva photo

"The patterns may be useful to detect episodes of opioid use in real time," says lead author Stephanie Carreiro, MD, a professor of Emergency Medicine at the University of Massachusetts Medical School. "The ability to identify instances of opioid use and opioid tolerance in real time could for instance be helpful to manage pain or during substance abuse treatment."

Carreiro and her colleagues say wearable devices could help identify pain patients at risk for substance abuse or addiction. They could also be used to remotely monitor patients enrolled in addiction treatment programs to detect whether they are relapsing.

“Wearable biosensors show a consistent physiologic pattern after opioid administration in an ED (emergency department) population,” they said. “This biometric response shows some distinguishing features between heavy and non-heavy opioid users in a controlled ED setting. This pattern may be useful to detect episodes of opioid use in real time. Further study is needed to evaluate the potential diagnostic and interventional applications of these devices in drug abuse treatment and pain management."

The Q sensor was initially developed to monitor children with epilepsy or autism, but they’ve since grown into a tool used in consumer focus groups to measure responses to advertising. They’re also being tested in middle schools as an “engagement pedometer” to measure if students are interested in a particular subject.

Critics say the technology is creepy and the data it generates can easily be misinterpreted.

"In high school biology I didn't learn a thing all year, but boy was I stimulated. The girl who sat next to me was gorgeous. Just gorgeous," Arthur Goldstein, an English teacher and critic of the technology told Reuters.

Affectiva recently raised $14 million in funding to develop facial recognition software for video games.  

AMA Defends Dropping Pain as Vital Sign

(Editor’s note: Last week we published a story on the American Medical Association’s decision to support the removal of pain as a “fifth vital sign” in professional medical standards – a move that some believe will make it harder for pain patients to be properly diagnosed and treated. Patrice Harris, MD, Chair of the AMA’s Board of Trustees, sent us the following letter objecting to how the AMA’s vital sign policy was characterized by PNN.)

By Patrice A. Harris, MD, Guest Columnist

The American Medical Association (AMA) unequivocally supports a patient’s right to receive the highest level of compassionate, comprehensive care for his or her pain.  It is unfortunate that the recent actions at the AMA House of Delegates were painted as anti-patient (“AMA Drops Pain as Vital Sign”), when the actual debate was focused entirely on how to ensure physicians have the necessary tools to deliver optimal care to our patients. 

Reducing the stigma of pain and advocating for comprehensive pain care are key recommendations from the AMA Task Force to Reduce Opioid Abuse – part of our multifactorial plan to ensure that balanced policies are in place to ensure patient’s access to care and promote the best evidence-based pain management practices, while reversing the nation’s opioid misuse, diversion, overdose and death epidemic.

When called for by a physician’s clinical judgment, this includes the use of opioid analgesics as a potential component of individual treatment plans.

Contrary to the claims in the article, however, our new policies complement and further our longstanding advocacy that emphasize the importance of treating each patient as an individual and tailoring care for that individual.

PATRICE HARRIS, MD

Pain satisfaction surveys, physician satisfaction surveys, even the Joint Commission’s Pain Care standards have not been shown to result in comprehensive improvements in pain treatment or protocols, or improved outcomes, but are clearly motivating forces for opioid prescribing. 

Patients with chronic pain deserve to benefit from the research and scientific approaches as envisioned by the National Pain Strategy, which the AMA strongly supports.  Not a single physician said, suggested, or hinted that anyone should “stop asking patients about their pain” as your recent article suggested.  Perpetrating this baseless, stigmatizing claim does your readers a tremendous disservice and does not reflect the opinions or practice of the nation’s physicians. 

We are well-aware that efforts to reduce the supply of opioids in the United States, without due consideration for unintended consequences and impact on chronic pain patients, have taken firm hold, and that many such patients have experienced disruption in their care and suffered. Many physicians at the AMA meeting decried the stigma that their patients experience. Others highlighted the audits and investigations by law enforcement among their colleagues.  And many noted the importance of treating all physical, psychosocial and behavioral aspects of pain. 

Furthermore, all discussed the importance of effective, evidence-based care, including the fact that vital signs are those that can be objectively measured and quantified. Identifying, treating and managing pain is central to medical practice, but it is not a readily quantifiable physiologic vital sign.  

We recognize that the pendulum has clearly swung too far. We know that the stigma of pain and opioid use has become pervasive, and we believe physicians and patient advocates must work together to restore balance.  But we can’t ignore the fear and stigma that pervades our society – and affects physicians and other health care professionals. We see (and experience) the increased scrutiny by law enforcement and government regulators.

In response, some physicians no longer treat chronic pain or prescribe opioids. But there are committed physicians in every city, town and state who provide the type of compassionate care that our patients need and deserve.  There are many examples of physicians doing all that is necessary to provide the type of complex, thoughtful care that chronic pain patients need. That is the vision we have for pain care in the United States.

We will, always stand up and speak out in support of patients who are in pain. We have done this countless times in Congress, with our state and specialty society colleagues, in front of the National Association of Counties, National Conference of Insurance Legislators, National Governors Association and many other leading organizations. 

We know all too well that pain is the number one reason patients come to us. We will continue to seek all avenues to provide the care our patients need – whether pharmacologic or non-pharmacologic – and insist that insurers cover the multimodal therapies required for effective management of chronic pain. 

The nation’s opioid misuse, overdose and death epidemic has harmed far too many, and the AMA is committed to working to ensure that patients with pain are not among those who must now become innocent bystanders in the regulatory response to this public health epidemic. To suggest anything less is to ignore the body of our advocacy and the mission that is central to our proud history.

Patrice A. Harris, MD, is Chair of the AMA Board of Trustees and Chair of the AMA’s Task Force to Reduce Opioid Abuse. A practicing psychiatrist based in Atlanta, Dr. Harris has served on the board of the American Psychiatric Association, as President of the Georgia Psychiatric Physicians Association and as Director of Health Services for Fulton County, GA.

Pain News Network invites other readers to share their stories with us.  Send them to:  editor@PainNewsNetwork.org. 

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

U.S. ‘Inundated’ with Fake Fentanyl Pills

By Pat Anson, Editor

With much of the U.S. focused on the so-called epidemic of prescription opioid abuse, another deadly problem is quietly taking root around the country: illicit fentanyl being sold as counterfeit pain medication.

“It’s unreal. They’re inundated with fentanyl in the Midwest and in the northeast,” says DEA spokesman Rusty Payne. “A lot of these fentanyl pills are being marketed as knockoff oxy (oxycodone).”

We first began reporting on the fake fentanyl pain pills in April, when 14 deaths in California and 9 in Florida were blamed on counterfeit medication.  Since then, the problem has spread to virtually every state.

In Massachusetts, Boston police are warning about counterfeit fentanyl pills that are nearly indistinguishable from prescription oxycodone.

“This dangerous drug is being sold to buyers who presume the pills, which are accurately formed and marked with the designation A/215, are Oxycodone 30 mg tablets. Anyone who ingests these Fentanyl pills may put themselves in serious danger of overdosing which can result in death,” police said.

In Layton, Utah, at least one recent overdose death is blamed on counterfeit roxicodone with the same markings.

LAYTON POLICE DEPT. PHOTO

“If you locate prescription pills with roxicodone markings "A" and "215" and you aren't sure where they originated from - use caution in handling them as you can absorb fentanyl through your skin,” the Layton police department warned in recent a Facebook post. “Counterfeit prescription pills are being made by street drug dealers and sold on the street, as they are cheaper and easier to obtain.”

In West Virginia, officials are investigating three non-fatal overdoses possibly caused by fentanyl disguised as Xanax, an anti-anxiety medication.

“You can tell it’s not really Xanax — if you look at the two they look the same, but not quite,” Dr. Elizabeth Scharman, director of the West Virginia Poison Center, told the Charleston Gazette-Mail. “The brand-name 2-milligram Xanax tablets are not that popular, so many people haven’t seen them before, and to them they look the same.”

And in Alabama, a routine traffic stop this week led to the arrest of a man with a vial of marijuana and a bag full of 78 white tablets. The pills looked similar to Xanax, but when tested were found to contain fentanyl.

Buyers Playing Russian Roulette

Fentanyl is a synthetic opioid that is 50 to 100 times more potent than morphine and can be lethal in very small doses. It is available legally by prescription in patches and lozenges to treat more severe types of acute and chronic pain, but illicitly manufactured fentanyl is fast becoming a scourge across the U.S. and Canada.

“It’s just Russian roulette,” says the DEA’s Payne. “Pharmaceutical grade fentanyl that you have in hospitals and such, that’s really not what we’re talking about here. We’re talking about black market, underground labs in China that are manufacturing this stuff.”

Unsuspecting buyers, including some pain patients who were unable to get opioid medication legally, have no idea the drug they’re getting from a dealer or friend could be lethal.  The dealers may be killing their own customers, but they’re driven by profit.

“We found that the profit margin in fentanyl is so much larger than heroin. And so have the Mexican cartels and the drug organizations,” said Payne. “A kilo of fentanyl versus a kilo of heroin on the street, when you cut it up and adulterate it enough to get it ready for street level distribution, they’re making a million to two million dollars from a kilo of fentanyl versus $80,000 for a kilo of heroin. So finances and profit are really playing a part in this. And you’ve got people here who are so addicted to opioids that there’s a market for it unfortunately.

In the past year, the DEA has issued two public safety alerts about fentanyl, but the Centers for Disease Control and Prevention (CDC) has remained relatively quiet about the problem – focusing instead on guidelines to reduce the prescribing of legal opioid medications.  So have many politicians, who have railed against opioid prescribing while supporting more federal funding for addiction treatment.

But the fentanyl problem is becoming too big to ignore.

States like Massachusetts, Rhode Island, Ohio and Delaware have reported an “alarming surge” in fentanyl related deaths in recent months. In some states, the number of deaths from fentanyl now exceeds those from prescription opioids.

“We think fentanyl and fentanyl overdoses have been underreported over the years in a lot of places. But we think people are now starting to pay more attention to it,” says Payne.

What no one seems willing to admit is that – while fentanyl dealers may be killing their customers – restricting access to legal opioids may only be creating new ones. In Canada’s western province of British Columbia, where fentanyl is involved in over half the drug overdoses, regulators have adopted opioid prescribing guidelines that are even more stringent than the CDC’s.

“The guidelines will make it much harder for pain sufferers, but will do absolutely nothing to discourage abuse and addiction. That population just goes on to something else as we all know from history,” said Barry Ulmer, Executive Director of the Chronic Pain Association of Canada.

The guidelines are forcing pain sufferers like Hugh Lamkin to buy fentanyl off the street because doctors won't give him an opioid prescription for arthritis and chronic back pain.

"I don't want to be buying street drugs," Lampkin told CBC News. “I think that I have a legitimate medical condition where I should be getting medication from my doctor."

Heroin Use Reaches 20-year High in U.S.

Limits on opioid prescribing may also be fueling a surge in heroin use in the United States, according to the chief researcher for a United Nations report on worldwide drug use.

"There is really a huge epidemic (of) heroin in the U.S.," Angela Me told Reuters.

According to the U.N. World Drug Report 2016, the number of heroin users in the U.S. reached one million in 2014, the highest in 20 years. Heroin use has increased sharply over the last two years in both North America and Europe.

The increase has coincided with a drop in heroin prices, but Me believes it could also be connected to the development of abuse deterrent formulas for OxyContin and other opioid pain medications, which have made the pills harder to crush and snort.

"This has caused a partial shift from the misuse of these prescription opioids to heroin," Me said.

Pain Care Shouldn’t Be Political Theater

By Richard Oberg, MD, Guest Columnist

The current hysteria over opioid pain medication is, without a doubt, the most unbelievable and difficult situation for patients I've ever seen in my 30 years of practice. With an increasing number of deaths due to overdose, the message has become that opioid medication is the problem. 

Healthy people, including healthy physicians, don't seem to believe chronic pain really exists to the degree that it does. Add in media hysteria with gross misrepresentation of the facts, often-cited CDC propaganda, and you have a recipe for disaster: addiction models applied to chronic pain patients.

Everyone's favorite defense mechanism – projection -- is overused constantly and many healthy people really think if they had chronic pain they'd somehow handle it differently or “beat it” which is nonsense.

Empathy is not a learned skill, nor is it widely prevalent in the population, including the majority of physicians. You feel it every time you see that look of disbelief from anyone, including physicians, regarding your chronic painful illness. Skepticism overrides compassion.  This attitude in the current climate has led to a crisis for patients.

At age 39, before I was diagnosed with psoriatic arthritis and eventually late stage complications of spondylitis and neuropathy, I was a multi-mile runner and very active member of our large hospital staff. Then suddenly every step was like walking on broken glass, aching everywhere with flu-like symptoms, and getting maybe two hours of sleep per night.

I saw multiple colleagues who'd give me a pat on the back and tell me to “hang in there” as I was heading for a meltdown.  Instead of a rheumatologist, I was sent to a psychiatrist.  Even after I got a definitive diagnosis, everyone still just chose to ignore it.

Sound familiar?

RICHARD OBERG, MD

I finally found an “old school” internist, one of the few in our area willing to treat chronic pain, who convinced me to try opioid medication cautiously, despite my reservations.  Like many people, I thought they'd make me fuzzy headed (bad for a diagnostic pathologist spending 8 hours under a microscope), but the opposite happened. Suddenly I was back at a tolerable pain level and able to sleep at night again. I’ll never forget how compassionate he was.

Biologic drugs such as Enbrel, which were new then, helped a lot for maybe 12 years. Over time they can become less effective for many patients. I became severely allergic to Remicade (anaphylactic reaction) and all other biologic/systemic medications also ceased to do anything, including Rituxan, which is for rheumatoid arthritis and B-cell lymphoma. I was desperate to continue working and was only able to with opioid medication.

Opioid Propaganda

So here's our dilemma as pain patients: we have a major federal agency (CDC) peddling “addictionologist” propaganda on a massive scale and investigative journalism no longer exists. The news media is no longer the fourth branch of government, but merely a vehicle for their propaganda.

Our physicians, despite being the highest paid in the world in the most expensive healthcare system in the world, have signed onto this -- not wanting any scrutiny whatsoever from state or federal regulators. They won't script in these “militarized” situations, and are either risk averse or co-dependent (the latter is why they want to drop the pain scale). Most are going along with the CDC because they don't want the extra trouble and have abandoned patient responsibility entirely, going for the low hanging fruit of more routine healthcare issues instead.

We have a supply and demand situation working against us with too few providers, an abundance of chronic pain patients, and pills that aren't as profitable as procedures. This varies from state to state and even within states, but is rapidly spreading. Physicians obviously caused part of the problem by over-prescribing, but they have the money and power, and are now just walking away from it all. There is a deafening silence from physicians, even when they know their patients are being abused.

In many states, like Tennessee where I live, physicians run everything. State officials passed tort reform, so lawyers won't take medical cases anymore (we tried and know firsthand).  Physicians own our state malpractice insurer, State Volunteer Mutual, which brags every year about malpractice premium refunds due to a decreased numbers of lawsuits. It's not because our state has a phenomenal group of physicians, it's just that the bar for a lawsuit is so high (like death of someone young) there are very few of them.

Within relatively few years (partly due to addictionologists like Dr. Andrew Kolodny having an outsized voice at the CDC) the conversation went from the “epidemic” of overdose deaths (which it never really was) to “opioids don't work for chronic pain” -- despite the fact that there are no good studies to support that because they really haven't been done.

They just say it and the news media repeats it, much like Dr. Sanjay Gupta, who stated on CNN’s “Prescription Addiction: Made in the USA” that overdoses were the #1 cause of preventable deaths in the Unites States. 

Sorry Sanjay, not even close. The CDC’s own statistics state that smoking and alcohol are the leading causes, with about 480,000 people dying every year – 25 times higher than the alleged 19,000 dying from prescription opioid medications.

How does this blatant propaganda get on CNN and what makes Sanjay Gupta an expert?

The ridiculous Consumer Reports cover story, The Dangers of Painkillers, also misused information supplied by the CDC. I've had a running email conversation with someone there for over a year asking why the bogus misuse of data - and got no answers of course.

Perhaps one of the most abominable statistical misuses by the CDC is confirmation bias, where they cherry pick data to “confirm” what they want to peddle, while ignoring other data, like the vast majority of pain patients doing well with opioid medication and most not having addiction issues.

Their argument simply doesn't work. In the 1990’s, the first decade of “massive” opioid prescribing that media outlets love to cite, there was no similar increase in complications caused by the number of “highly addictive” pills being prescribed. Then we had the 2008 financial meltdown, society changed, drug addiction became a prominent issue, and suddenly people were dying from too many pills.

Finally, the artificial breakdown of “cancer” pain vs. “non-cancer” pain is complete nonsense and always has been. The final common denominator of pain is pain, and cancer is merely one of many etiologies that can cause it.

Incidentally, the word “cancer” is pretty meaningless, especially to a pathologist like me. Large numbers of physicians and virtually all lay people have little understanding of the pathophysiologic processes pathologists are trained to understand.  Most things called “cancer” aren’t chronically painful and many autoimmune diseases can be much more painful than cancer.

Ironically, as cancer treatments have become better (such as those for breast cancer) and with longer survival times, many cancer patients are developing chronic pain conditions that have nothing to do with their cancer.

Do they get special treatment even if they have a good long-term prognosis?

Richard Oberg, MD, is disabled by psoriatic arthritis and no longer practices medicine. Dr. Oberg receives no funding from pharmaceutical manufacturers. 

Pain News Network invites other readers to share their stories with us.  Send them to:  editor@PainNewsNetwork.org. 

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

AMA Drops Pain as Vital Sign

By Pat Anson, Editor

The nation’s largest medical society is recommending that pain be removed as a “fifth vital sign” in professional medical standards – a move critics say will make it even more difficult for pain sufferers to have their pain properly diagnosed and treated.

Delegates at the annual meeting of the American Medical Association in Chicago also passed several other resolutions aimed at reducing opioid prescribing and increasing access to addiction treatment. The AMA represents over 200,000 physicians in the U.S. and is very influential in setting public health policy.

The AMA’s new president said physicians played a key role in starting the so-called opioid epidemic by overprescribing pain medication, and now must do their part to end it.

“We have taken ownership of that, and physicians have taken ownership of being part of the solution,” AMA president Andrew Gurman, MD, told Modern Healthcare.

The AMA’s main “solution” to the opioid problem is to stop asking patients about their pain.

Pain was first recognized as the fifth vital sign in the 1990's, giving pain equal status with blood pressure, heart rate, respiratory rate and temperature as vital signs. The policy encourages healthcare providers to ask patients about their pain.

But critics say pain is not a vital sign, but more of a symptom, and cannot be measured like a patient's temperature or blood pressure. They also claim The Joint Commission,  a non-profit that accredits hospitals and other U.S. healthcare organizations, sets pain management standards too high, which contributes to opioid overprescribing.

"Just as we now know (the) earth is not flat, we know that pain is not a vital sign. Let's remove that from the lexicon," James Milam, MD, an AMA delegate said in MedPage Today. "Whatever it's going to take to no longer include pain as a vital sign ... Let's just get rid of the whole concept and try to move on."

“I am astounded that physicians don't believe we should assess pain on a regular and ongoing basis. That is exactly what removing pain as a vital sign means,” said Lynn Webster, MD, past president of the American Academy of Pain Medicine and vice president of scientific affairs at PRA Health Sciences.

Webster says dropping pain as a vital sign would setback pain care three decades.

“The problem is that too many physicians and policymakers equate assessing pain with giving opioids,” he said in an email to Pain News Network. “It appears that advocates for removing pain as a 5th vital sign are suggesting that if we just ignore pain then we won't have to deal with pain and opioid abuse will disappear. That is not only fantastical thinking, it is harmful to millions of people in pain.” 

"This is a very unfortunate decision, one that creates the very real possibility that we will see a decrement in the quality of pain care delivered in various institutions," warned Bob Twillman, PhD, Executive Director of the Academy of Integrative Pain Management.

"The Joint Commission standards say you need to assess pain in every patient; record the results of that assessment; provide some kind of treatment; re-assess to see if the treatment was effective; and teach staff how to manage pain. They do not say we should ask patients how much pain they have on a 0-10 scale and give them opioids until the pain level is 4 or less. Not asking about pain does not make pain go away, and it does not relieve healthcare providers of their moral and ethical obligation to treat that pain effectively."

AMA Adopts PROP Policies

AMA delegates also passed a resolution urging The Joint Commission to stop requiring hospitals to ask patients about the quality of their pain care. Medicare has a funding formula that requires hospitals to prove they provide good care through patient satisfaction surveys.  The formula rewards hospitals that are rated highly by patients, while penalizing those that are not. 

"Judging health care facilities on an overly subjective measure – that is, how well it is perceived that they treat pain -- is an overly simplistic approach to measuring clinical effectiveness," said AMA Board chair Patrice Harris, MD, in a statement.

Passing the two resolutions means the AMA has essentially adopted the same policies as Physicians for Responsible Opioid Prescribing (PROP), which is also lobbying the Joint Commission to weaken its pain management standards.  PROP is funded by Phoenix House, which runs a chain of addiction treatment centers. 

“At a time when millions of individuals in pain are under siege, the AMA has made it clear they are no friend to people in pain as they are opposed to being accountable for the pain care they provide, “ said David Becker, a patient advocate and social worker. “The AMA has become regressive, vision less, and hard-hearted toward the suffering that millions of people in pain endure on a daily basis. It is clear that the AMA is in need of moral reform.”

A recent survey of over 1,200 patients by Pain News Network and the International Pain Foundation found that many were dissatisfied with their pain treatment in hospitals. Over half rated the quality of their pain care as either poor or very poor, and over 80% said hospital staff are not adequately trained in pain management.

The AMA House of Delegates also passed a resolution calling for greater access to naloxone, which reverses the effects of an opioid overdose, and adopted a policy urging health insurers to increase coverage of non-opioid and non-pharmacological pain treatments.

“Insurers must cover non-opioid and non-pharmacologic therapies that have proved effective. Insurers must take a broader view to give patients and physicians more choices," said Harris. “These policies will save lives. That's the bottom line.”

Study Finds Heart Disease Biggest Risk from Opioids

By Pat Anson, Editor

People who take opioid medication for chronic pain are far more likely to die prematurely from cardiovascular and respiratory problems than they are from accidental overdoses, according to researchers at Vanderbilt University.

Their study, published in JAMA, suggests that many opioid related deaths have been misclassified as overdoses and that public health policy should be more focused on the risks of opioids causing cardiovascular problems.

Researchers looked at a database of nearly 23,000 Medicaid patients in Tennessee who were prescribed either opioids; anti-seizure nerve medications such as pregabalin (Lyrica) and gabapentin (Neurontin); or a low dose antidepressant for chronic non-cancer pain.  

After four months, there were 185 deaths in the opioid group, a mortality rate that that was 1.6 times greater than the patients taking anti-seizure drugs or antidepressants. More than two-thirds of the excess deaths were due to causes other than accidental overdose.

Over twice as many patients died from cardiovascular and respiratory problems (89) than from overdoses (34).

“The increased risk of cardiovascular death could be related to adverse respiratory effects of long-acting opioids. Opioids can cause or exacerbate sleep-disordered breathing, including both obstructive and central sleep apnea,” wrote lead author Wayne Ray, PhD, of the Vanderbilt University School of Medicine.

“More than two-thirds of the excess deaths for patients in the long-acting opioid group were not coded as being due to unintentional overdose. If there is this degree of misclassification, then previous research on opioid mortality, most of which has focused on overdose deaths identified from death certificates, has substantially underestimated the true risks of opioids.”

The Centers for Disease Control and Prevention uses death certificate codes in its reports on mortality. The agency estimates that nearly 19,000 Americans died from overdoses of prescription pain medication in 2014. However, CDC researchers admit some of the overdoses may have been counted twice, and that some overdoses from illicit opioids such as heroin and fentanyl may have been counted as prescription drug deaths.

One weakness of the Vanderbilt study is that it only looked at mortality rates in the first few months of treatment and did not include deaths from long-term medication use.

“The study finding that prescription of long acting opioids was associated with increased cardiovascular and other non-overdose mortality adds to the already considerable known harms of the opioids and thus should be considered when assessing the benefits and harms of medications for chronic pain,” Ray wrote. “Nevertheless, for some individual patients, the therapeutic benefits from long-acting opioid therapy may outweigh the modest increase in mortality risk.”

The mortality rate for chronic pain patients who died in a hospital was higher for patients given antidepressants and anti-seizure drugs than it was for opioids.